Delivery cylinder for prosthetic implant

ABSTRACT

A delivery cylinder for a prosthetic implant can include a first tubular portion and a second tubular portion. The second tubular portion has a plurality of strut members coupled to the first tubular portion that define a volume for containing the prosthetic implant in a radially compressed state. The strut members can include respective flex regions configured such that application of force to the strut members causes deformation of the flex regions and corresponding radially inward or outward movement of the strut members relative to a longitudinal axis of the delivery cylinder between an expanded configuration and a contracted configuration.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 62/305,351, filed Mar. 8, 2016, which is incorporatedherein by reference in its entirety.

FIELD

This application relates to delivery assemblies for prosthetic implantssuch as transcatheter heart valves.

BACKGROUND

Prosthetic implants such as self-expanding transcatheter heart valvesare typically housed in a delivery cylinder that constrains theprosthetic valve to maintain it in a radially compressed state. Suchdelivery cylinders typically have a relatively small diameter tofacilitate insertion of the delivery cylinder through an introducersheath into the body and through narrow vessels toward an implantationsite. While the valve is contained in the delivery cylinder, the valveexerts radial force against the walls of the delivery cylinder. Duringdeployment of the prosthetic valve, the valve can be partially advancedfrom the delivery cylinder and retracted into the delivery cylinder orrecaptured as needed to properly position the valve in the nativeannulus. The recapture process can exert substantial axial or columnarforce on the delivery cylinder as the prosthetic valve is urged backinto the radially compressed state by the walls of the deliverycylinder. Making the walls of the delivery cylinder strong enough towithstand the radial forces exerted by the valve in the compressed stateand the axial forces exerted during valve recapture results in anincreased diameter of the delivery assembly, which can complicateinsertion and access to the implantation site. Accordingly, improvementsto delivery cylinders for prosthetic implants are desirable.

SUMMARY

This summary is meant to provide some examples and is not intended to belimiting of the scope of the invention in any way. For example, anyfeature included in an example of this summary is not required by theclaims, unless the claims explicitly recite the features. Also, thefeatures, steps, concepts, etc. described in examples in this summaryand elsewhere in this disclosure can be combined in a variety of ways.

Certain embodiments of the disclosure concern delivery cylinders forprosthetic implants and methods of using the same. A delivery cylinderfor a prosthetic implant can comprise a first tubular portion and asecond tubular portion. The second tubular portion can comprise aplurality of strut members coupled to the first tubular portion anddefining a volume for containing the prosthetic implant in a radiallycompressed state. The strut members can include respective flex regionsconfigured such that application of force to the strut members causesdeformation of the flex regions and corresponding radially inward oroutward movement of the strut members relative to a longitudinal axis ofthe delivery cylinder between an expanded configuration and a contractedconfiguration. The delivery cylinders can include any of the features orcomponents described here or described elsewhere in this application.

An assembly and/or system can comprise a shaft having a proximal endportion and a distal end portion, and a delivery cylinder (e.g., thedelivery cylinder described above or any of the delivery cylindersdescribed elsewhere in this application) coupled to the distal endportion of the shaft and including a plurality of strut members defininga tubular portion. The strut members can include respective flex regionsconfigured such that application of force to the strut members causesdeformation of the flex regions and corresponding radially inward oroutward movement of the strut members relative to a longitudinal axis ofthe delivery apparatus between an expanded configuration and acontracted configuration. The assembly and/or system can furthercomprise a prosthetic implant retained in a radially compressed state inthe delivery cylinder. The assembly and/or system can include any of thefeatures or components described here or described elsewhere in thisapplication.

Various methods can comprise deploying a prosthetic implant in aradially compressed state from a delivery cylinder (e.g., the deliverycylinder described above or any of the delivery cylinders describedelsewhere in this application) including a plurality ofcircumferentially arranged strut members such that the prostheticimplant at least partially expands to a functional size and the strutmembers move radially inwardly from an expanded configuration to acontracted configuration. The method(s) can further comprise recapturingthe prosthetic implant such that the prosthetic implant is at leastpartially returned to the radially compressed state by the deliverycylinder, and the strut members move radially outwardly such that thedelivery cylinder returns to the expanded configuration. The method(s)can also include any of the steps described here or described elsewherein this application.

Various methods can comprise inserting a delivery assembly including adelivery cylinder (e.g., the delivery assemblies/systems and deliverycylinders described above or any of the delivery assemblies/systems anddelivery cylinders described elsewhere in this application) containing aprosthetic implant in a radially compressed state into an introducersheath such that a plurality of circumferentially arranged strut membersof the delivery cylinder move radially inwardly from an expandedconfiguration to a contracted configuration to conform to a diameter ofthe introducer sheath. The method(s) can further comprise advancing thedelivery apparatus through the introducer sheath and into a patient'sbody such that the strut members move radially outwardly and return tothe expanded configuration. The method(s) can also include any of thesteps described here or described elsewhere in this application.

The foregoing and other objects, features, and advantages of thedisclosed technology will become more apparent from the followingdetailed description, which proceeds with reference to the accompanyingfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the inventions. In addition, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure. Throughout the drawings, referencenumbers may be reused to indicate correspondence between referenceelements.

FIG. 1 is a perspective view of a representative embodiment of aprosthetic implant delivery device.

FIG. 2 is a perspective view of the prosthetic implant of the deliveryassembly of FIG. 1.

FIGS. 3 and 4 are perspective views of a representative embodiment of adelivery cylinder including two strut members.

FIG. 5 is a side-elevation view of the delivery cylinder of FIG. 3 in acontracted position within an introducer sheath.

FIG. 6 is a side-elevation view of the delivery cylinder of FIG. 3 in anexpanded configuration.

FIG. 7 is a plan view of another embodiment of a delivery cylinderincluding three strut members flattened for purposes of illustration.

FIG. 8 is a plan view of another embodiment of a delivery cylinderincluding four strut members flattened for purposes of illustration.

FIGS. 9 and 10 are perspective views of the delivery cylinder of FIG. 8.

FIG. 11 is a perspective view of a distal end portion of the deliverycylinder of FIG. 3.

FIG. 12 is a perspective view of another embodiment of a deliverycylinder integrally formed with an outer catheter of a deliveryassembly.

FIG. 13 is a perspective view of a representative embodiment of a wovenliner.

FIG. 14 is a perspective view of a prosthetic implant being recapturedin the delivery cylinder of FIG. 3.

FIGS. 15 and 16 are perspective views illustrating an embodiment of adelivery assembly delivering a prosthetic implant into a patient'sheart, shown in partial cross-section.

FIG. 17 is a perspective view of another embodiment of a deliverycylinder positioned in a descending aorta with a woven liner disposedover the delivery cylinder.

FIG. 18 is a perspective view of the delivery cylinder of FIG. 17 withthe woven liner disposed proximally of the delivery cylinder and thedelivery cylinder in an expanded configuration.

FIG. 19 is a perspective view of another embodiment of a deliverycylinder.

FIG. 20 is a process flow diagram illustrating a representative methodof deploying a prosthetic implant.

FIG. 21 is a process flow diagram illustrating a representative methodof advancing a delivery cylinder through a sheath.

DETAILED DESCRIPTION

Although certain preferred embodiments and examples are disclosed below,inventive subject matter extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and tomodifications and equivalents thereof. Thus, the scope of the claimsthat may arise herefrom is not limited by any of the particularembodiments described below.

FIG. 1 illustrates an exemplary embodiment of a prosthetic implantdelivery assembly 100 that can be adapted to deliver and implant aprosthetic implant, such as a transcatheter heart valve, in a tubularorgan or passageway in the body, such as a native valve annulus of theheart. In the illustrated embodiment, the delivery assembly 100 cancomprise a prosthetic heart valve 102 releasably coupled to a deliveryapparatus 104.

A wide variety of prosthetic implants/valves can be used with thedelivery assemblies, apparatuses, cylinders, systems, etc. describedherein, including self-expandable implants/valves, balloon-expandableimplants/valves, mechanically-expandable implants/valves, stents,grafts, etc. and/or a combinations of some or all of these. Referringnow to FIG. 2, the prosthetic valve 102 is a non-limiting example of animplant/valve that can be used. The prosthetic valve 102 can comprise anannular stent or frame 106 and a valve structure 108 which is coupled tothe frame 106. The prosthetic valve 102 can have in inflow end portion110, an intermediate portion 112, and an outflow end portion 114.

The frame 106 can comprise a plurality of interconnected struts 116arranged in a lattice-type pattern and forming a plurality of apices 118at the inflow and outflow ends 110, 114 of the prosthetic valve 102. Allor at least some of the apices 118 at the outflow end 114 of theprosthetic valve 102 can have a respective aperture or opening 120formed therein (e.g., three in the illustrated embodiment). In oneembodiment, none of the apices 118 include an aperture or opening 120.In implants where openings 120 are included, the openings 120 can beused to, for example, releasably couple the prosthetic valve 102 to thedelivery apparatus 104. In implants where no openings 120 are included,other ways of releasably coupling the prosthetic valve 102 to thedelivery apparatus 104, e.g., one or more sutures releasably passingthrough cells of the frame can be used and/or other coupling elementscan be used.

The apices 118 having the openings 120 can be arranged in various waysrelative to each other and relative to the other apices 118 at theoutflow end 114 of the prosthetic valve 102. For example, the apices 118having the openings 120 can be uniformly (e.g., symmetrically)distributed circumferentially around the outflow end 114 of theprosthetic valve 102 relative to the other apices 118 at the outflow end114 of the prosthetic valve 102. The apices 118 with the openings 120can be referred to as connecting arms, or connecting posts, extensions,and can be longer than the apices without the openings 120.

The frame 106 can be made of any of various suitableplastically-expandable materials (e.g., stainless steel, etc.) orself-expanding materials (e.g., shape memory materials, nickel titaniumalloy (“NiTi”), such as Nitinol). When constructed of aplastically-expandable material, the frame 106 (and thus the prostheticvalve 102) can be crimped to a radially collapsed configuration or stateon a delivery catheter and then expanded to a functional size inside apatient by an inflatable balloon or equivalent expansion mechanism. Whenconstructed of a self-expandable material, the frame 106 (and thus theprosthetic valve 102) can be crimped to a radially collapsedconfiguration and restrained in the collapsed configuration by insertioninto a sheath or equivalent mechanism of a delivery catheter. Onceinside the body, the prosthetic valve can be deployed from the deliverysheath, and the prosthetic valve can radially expand to its functionalsize.

Further details regarding collapsible transcatheter prosthetic heartvalves, including the manner in which the valve structure 108 can becoupled to the frame 106 of the prosthetic valve 102 can be found, forexample, in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394,and 8,652,202, which are incorporated herein by reference in theirentirety.

Referring again to FIG. 1, the delivery apparatus 104 can comprise ahandle 122, an outer catheter 124, a release catheter 126, and a lockingcatheter 128. The handle 122 can be disposed at the proximal end portion132 of the delivery apparatus 104. The outer catheter 124, the releasecatheter 126, and the locking catheter 128 can extend coaxially along alongitudinal axis 134 from the proximal end 132 of the deliveryapparatus 104 toward an opposite, distal end portion 136 of the deliveryapparatus 104. The release catheter 126 and the locking catheter 128 canbe disposed coaxially within and extend through a lumen of the outercatheter 124. The locking catheter 128 can be disposed coaxially withinand extend through a lumen of the release catheter 126.

The outer catheter 124 can comprise a sheath portion 144 disposed at adistal end 146 of the outer catheter 124. The sheath 144 can be used toretain the prosthetic valve 102 in a radially compressed state duringdelivery of the prosthetic valve 102 through a patient's body, asfurther described below. In the illustrated embodiment, the outercatheter 124, the release catheter 126, and the locking catheter 128 caneach be independently moveable relative to each other by, for example,actuation of one or more controls on the handle 122.

The release catheter 126 can include a plurality of tines or arms 150 a,150 b, 150 c, collectively referred to as arms 150. The arms 150 canreleasably engage the prosthetic valve 102 at, for example, the openings120 of select apices 118 of the prosthetic valve (see, e.g., FIG. 2). Insome embodiments, the arms 150 can be independently movable in the axialdirection to position the prosthetic valve 102 (e.g., to orient alongitudinal axis 176 of the prosthetic valve at an angle to thelongitudinal axis 134 of the delivery apparatus). An inner catheter 130can be disposed coaxially within the release catheter 126, and cancomprise a nose cone 186 located at the distal end of the innercatheter.

FIG. 3 illustrates a representative embodiment of a delivery cylinder200 that can be used in combination with any of the deliveryassemblies/systems, and/or implants described herein. The deliverycylinder can include a main body portion 202 having a first proximaltubular portion 204 and a second distal tubular portion 206. In someembodiments, the first tubular portion 204 can be coupled to a distalend portion of an outer catheter, such as outer catheter 124 of FIG. 1.The second tubular portion 206 can include a proximal end portion 208and a distal end portion 210, and a plurality of circumferentiallyarranged strut members 212. The strut members 212 can also compriserespective main body portions 221 and proximal and distal end portions220, 222. In the illustrated embodiment, the proximal end portions 220can be coupled to the first tubular portion 204. In some embodiments,the strut members 212 can be integrally formed with the first tubularportion 204 such that the first tubular portion and the respective strutmembers are a one-piece unitary construction. Alternatively, the strutmembers 212 can be separately formed and coupled to the first tubularportion 204 by, for example, welding.

As shown, for example, in the illustrated embodiment, the strut members212 can define a chamber or volume 214 (see, e.g., FIGS. 4, 5, and 6)for containing a prosthetic implant, such as the valve 102 of FIG. 2, ina radially compressed delivery state. In the embodiment illustrated inFIGS. 3 and 4, the second tubular portion 206 includes twoconcave-convex strut members 212. However, it should be understood thatthe second tubular portion can include any suitable number of strutmembers having any suitable shape. For example, the delivery cylindercan have 2-20 strut members, e.g., four strut members (see, e.g., FIGS.8-10), twelve strut members (FIG. 19), etc., which can be curved orplanar or another shape, according to the particular application. Thestrut members 212 can also include a plurality of openings 250 atdifferent locations along the length of the strut members andcircumferentially spaced around the strut members to secure, forexample, a woven liner to the strut members, as further described below.

In the illustrated embodiment, the delivery cylinder can also include aflexible member or sleeve 242 coupled to the distal end portions of thestrut members and configured to, for example, elastically deform uponinsertion of a prosthetic implant into the delivery cylinder to reducedamage to the implant. The flexible member 242 can be made from anysuitable pliable biocompatible material, such as polyurethane orsilicone.

Referring to FIGS. 3-9, the strut members 212 can include respectiveflex regions 216. In the illustrated embodiment, the flex regions 216are located at the proximal end portions 220 of the strut members, andcan be configured to flex, bend, or otherwise deform such that the strutmembers are movable between a collapsed or contracted configuration(FIG. 5) and an expanded configuration (FIG. 6). In the illustratedembodiment, the flex regions 216 of the strut members can includerespective first and second bending portions 224, 226 separated byintermediate portions 228.

FIGS. 7 and 8 illustrate the bending portions 224, 226 in greater detailin the context of three- and four-strut member delivery cylinderembodiments, respectively, shown unrolled or flattened for purposes ofillustration. As shown in FIGS. 7 and 8, the first bending portions 224can be located adjacent the first tubular portion 204, and can bedefined by first cut-out or recessed portions 230A, 230B located on thesides of the strut members 212. The recessed portions 230A, 230B canreduce a width of the respective strut members at the location of thefirst bending portion 224 such that the strut members 212 can be inducedto bend at the first bending portion when radial force is applied to thestrut members (see, e.g., FIGS. 5 and 6).

For example, in some embodiments, a width W_(B) of the first bendingportions 224 can be from about 20% to about 90% of a width W_(S) of thestrut members 212. In the three-strut configuration illustrated in FIG.7, the width W_(B) of the first bending portions is about 60% of thewidth W_(S) of the strut members. In the four-strut configuration ofFIG. 8, the width W_(B) of the first bending portions is about 40% ofthe width W_(S) of the strut members, although it should be appreciatedthat the bending portions can have any suitable width depending upon thenumber of strut members, the flexural strength required, etc.

The second bending portions 226 can be defined by second cut-out orrecessed portions 232A, 232B defined in the sides of the strut membersdistally of the first recessed portions. The second recessed portions232A, 232B can be configured to induce the strut members to bend at thesecond bending portions 226 when radial force is applied to the strutmembers. In the illustrated embodiments, the respective widths of thefirst and second bending portions 224, 226 are substantially equal toone another. However, it should be appreciated that in alternativeembodiments, the widths of the first and second bending portions can bedifferent from one another. Additionally, the widths of the bendingportions can also be different between respective strut members, asdesired. Furthermore, although the first bending portions 224 and thesecond bending portions 226 of the respective strut members are locatedat substantially the same location along the lengths of the strutmembers as the respective first and second bending portions of the otherstrut members, it should be understood that the first and second bendingportions can be located at different locations along the lengths of thestrut members from one strut member to another. Further, in alternativeembodiments, the bending portions 224, 226 need not comprise therespective recessed portions 230A-230B, 232A-232B (see, e.g., FIG. 12).

Referring again to FIGS. 5 and 6, bending of the strut members 212 atthe first and second bending portions 224, 226 can allow the secondtubular portion 206 to radially expand and contract depending upon theradial forces exerted upon the strut members. For example, FIG. 5illustrates the delivery cylinder 200 within a lumen of an introducersheath 264 (shown in cross-section and spaced apart from the deliverycylinder for purposes of illustration) and coupled to an outer catheter252. The introducer sheath 264 can constrain the delivery cylinder andexert radially inward forces F₁ on the strut members 212 such that theflex regions 216 flex or deform, causing the strut members 212 to moveradially inward or toward the longitudinal axis 218 of the deliverycylinder into the contracted configuration. Thus, in the contractedconfiguration, the second tubular portion 206 can have a first diameterD₁, which can be substantially equal to an inner diameter of theintroducer sheath 264. Movement of the strut members to the contractedconfiguration can also cause corresponding radial compression of aprosthetic implant schematically illustrated at 234 contained in thesecond tubular portion 206 as the diameter of the second tubular portionis reduced.

Referring to FIG. 6, as the delivery cylinder is advanced from theintroducer sheath 264, radially outward force(s) indicated at F₂ appliedto the strut members 212 (e.g., by the compressed prosthesis 234) and/orthe shape-memory of the strut members can cause the flex regions 216 toflex or deform such that the strut members move radially outward or awayfrom the longitudinal axis 218 of the delivery cylinder into theexpanded configuration. This radially outward movement of the strutmembers 212 can cause the diameter of the second tubular portion 206 toincrease from the first diameter D₁ to a second diameter D₂ inproportion to the distance moved by the strut members. Moreparticularly, application of radially outward force F₂ can cause thefirst bending portions 224 of the strut members to bend radially awayfrom the longitudinal axis 218 such that an angle α (FIG. 6) definedbetween an exterior surface 236 of the first tubular portion 204 (or theouter catheter where the delivery cylinder is integrally formed with theouter catheter) and an exterior surface 238 of the respectiveintermediate portions 228 is less than 180 degrees.

Meanwhile the second bending portions 226 can bend in a directionradially toward the longitudinal axis such that an angle β definedbetween the respective exterior surfaces 238 of the intermediateportions 228 and respective exterior surfaces 240 of the main portions221 of the strut members is greater than 180 degrees. In this manner,the intermediate portions 228 can be angled relative to the longitudinalaxis 218 of the delivery cylinder when the strut members are in theexpanded configuration, while the main portions 221 of the strut memberscan be substantially parallel to the longitudinal axis. In theillustrated configuration, a diameter of the flexible member 242 canalso change between the first diameter D₁ and the second diameter D₂ asthe second tubular portion 206 moves from the contracted configurationto the expanded configuration. In some embodiments, the flexible membercan also limit radial expansion of the strut members. When the radiallyoutward forces F₂ are relieved (e.g., by deploying the prosthesis 234),the flex regions 216 can flex or deform such that the strut members 212return to the collapsed configuration illustrated in FIG. 5.

In some embodiments, D₁ can be about 3 mm to about 6 mm, being aspecific example. In some embodiments, D₁ can be about 4 mm to about 5mm. In certain embodiments, D₂ can be about 1% greater than D₁, about 3%greater than D₁, about 5% greater than D₁, about 10% greater than D₁,about 20% greater than D₁, about 50% greater than D₁, or about 100%greater than D₁.

Referring to FIGS. 9, 10, and 11, the flexible member 242 can beretained on the distal end portions 222 of the of the strut members 212by retaining mechanisms 244 (FIGS. 4, 11). In the illustratedembodiment, the retaining mechanisms 244 are a plurality of extensionportions 246 extending longitudinally from the distal end portions ofthe strut members 212 and including tip portions 248 having alongitudinal axis perpendicular to the extension portions 246. Theextension portions 246 can be positioned against an interior surface ofthe flexible member 242, or can be embedded within the flexible member.In this manner, the tip portions 248 can resist longitudinal movement ofthe flexible member to reduce or prevent, for example, detachment of theflexible member during deployment of the prosthetic device. In someembodiments, the extension portions 246 can be configured to bend ordeflect radially outwardly with the flexible member to, for example,facilitate recapture of the prosthetic device into the delivery cylinderas described in detail below. In some embodiments, the retainingmechanisms 244 need not comprise the tip portions 248. Furthermore, itshould be understood that the distal end portions of the strut memberscan include any suitable number of extension portions having anysuitable width dimension depending upon the strength and/or flexibilityproperties desired.

The delivery cylinder can be made from a variety of materials, such asany of various biocompatible metal alloys including stainless steel, ornickel titanium (“NiTi”) alloys such as Nitinol. In this manner, thestrut members 212 can provide axial or columnar strength to the deliverycylinder to resist buckling during loading or recapture of a prosthesis,as further described below. The various features of the deliverycylinder can be fashioned by, for example, laser-cutting the featuresfrom a tube. In some embodiments, the delivery cylinder can beintegrally formed with a tubular catheter structure such as the outercatheter 252, as shown in FIG. 12, by machining the appropriate featuresat the distal end of the outer catheter. In this manner, the firsttubular portion 204 of the delivery cylinder can be the distal endportion of the outer catheter 252. Alternatively, the delivery cylindercan be separately fabricated and joined to the outer catheter by, forexample, welding.

In some embodiments, the delivery cylinder 200 can be used incombination with a woven fabric sleeve or liner 300 illustrated in FIG.13. The liner 300 can comprise a woven tubular structure having a firstor proximal body portion 302 and a second or distal body portion 304with an intermediate portion 306 disposed therebetween. The distal bodyportion 304 can have a flared end portion 308 to enable the distal bodyportion to receive and retain a prosthetic implant in a compresseddelivery state. In the illustrated embodiment, the distal body portioncan have a diameter D₁ that is greater than a diameter D₂ of theproximal body portion 302. In some embodiments, the proximal bodyportion 302 can extend proximally from the delivery cylinder tointerface with other components of the delivery assembly, as needed. Inother embodiments, the woven liner 300 can comprise a single tubularportion having a substantially uniform diameter.

The woven liner 300 can be made from a woven fabric comprising warp andweft yarns woven in a plain, twill, basket, satin, and/or sateen weave.In certain embodiments, different weaves can be used at differentportions of the liner to achieve the desired properties. The warp andweft yarns can comprise natural or polymeric fibers, or combinationsthereof. For example, the yarns can be composite yarns with corescomprising high tenacity polyethylene terephthalate (PET) and/or nylon,and outer sheathing comprising higher lubricity materials such aspolytetrafluoroethylene (PTFE) to reduce friction (e.g., during valveinsertion).

The yarns can also be monofilament yarns or multi-filament yarns,depending on the particular characteristics desired. For example, incertain embodiments, monofilament yarns can be used in combination withmultifilament yarns to reinforce the strength of the woven liner atparticular portions of the woven structure. The yarns can also compriseround cross-sections and/or flat cross-sections. In some embodiments,the woven liner can have a pick density of about 500 picks per inch ormore, depending upon the radial strength properties desired. In someembodiments, the woven liner 300 can be made substantially seamlesslyon, for example, a circular loom or a shuttle-less loom. Thus, thecombination of the above features allows the woven liner to achieve highradial strength with fabric thicknesses of about 0.003 inch or less,which can result in a reduced diameter of a delivery assembly into whichthe woven liner is incorporated. In alternative embodiments, the wovenliner can be a non-fabric polymer layer or or film.

Referring again to FIGS. 5 and 6, the woven liner 300 (illustratedschematically) can be disposed inside the delivery cylinder such thatthe distal body portion 304 of the liner is located within the secondtubular portion 206 of the delivery cylinder 200, although it should beunderstood that the woven liner can also be disposed about the exteriorof the delivery cylinder. In some embodiments, the woven liner 300 canbe coupled to the delivery cylinder 200 by, for example, suturing thewoven liner to the delivery cylinder through the openings 250. In thismanner, when the prosthetic implant 234 is loaded into the deliverycylinder 200, the implant can be received in the woven liner 300, andlongitudinal motion of the liner relative to the delivery cylinder canbe minimized.

This configuration can provide a number of advantages over knowndelivery systems. For example, in cases where the prosthetic implant 234is a self-expanding device, such as a self-expanding prosthetic valve,the crimped implant can exert radially outward force F₁ against thewalls of the woven liner. Because the woven liner 300 provides highradial strength, the woven liner can retain the implant in the crimpeddelivery state and reduce the radial loading of the strut members 212.This allows the strut members 212 to be made of reduced thicknessmaterials. For example, in a representative embodiment where thedelivery cylinder is made from titanium or a titanium alloy, the wallthickness of the strut members can be about 0.005 inch or less, whichcan reduce the overall diameter of the loaded delivery cylinder.

This configuration can also provide significant advantages duringloading of the implant into the delivery cylinder, introduction of thedelivery assembly into the body, and deployment of the implant at thetreatment site. For example, by allowing the delivery cylinder toradially expand and contract, the degree of crimping required to insertthe prosthetic implant into the delivery cylinder can be reduced becausethe woven liner and the delivery cylinder can radially expand toaccommodate the crimped implant. This can also reduce the radial forcesexerted on the liner and the strut members when the delivery cylinder isin an unconfined environment.

The radial flexibility of the woven liner 300 and of the flex regions216 of the strut members 212 can also allow the second tubular portion206 to expand or contract to conform to the dimensions of a lumen intowhich the delivery cylinder is inserted. For example, when the deliverycylinder is inserted into a narrow passage, radially inward forceapplied to the strut members by the surrounding lumen can cause the flexregions to flex such that the strut members move toward the longitudinalaxis 218 of the delivery cylinder to assume the contracted configurationof FIG. 5. This can also further collapse the prosthetic implant withinthe delivery cylinder, allowing the delivery cylinder to be inserted andadvanced through, for example, an introducer sheath or narrow vessels inthe body. When the delivery cylinder is advanced into an unconfined or aless confined environment, such as upon exiting an introducer sheath orbeing advanced through a relatively large vessel (e.g., the aorta), thedelivery cylinder can return to the expanded configuration, allowing theimplant to expand a limited amount and commensurately reducing theradial forces applied to the woven liner and the strut members by theimplant. Thus, the ability to move between an expanded configuration anda contracted configuration enabled by the combination of the woven linerand the strut members allows the delivery cylinder to achieve a reduceddiameter during the parts of a procedure where such a reduced diameteris advantageous. The delivery cylinder can then return to an expandedconfiguration when a reduced diameter is unnecessary, which can reducethe radial loading on the woven liner and the strut members. The wovenliner 300 can be used in combination with flexible member 242, or one orthe other of these may be used alone.

The combination of the woven sleeve 300 and the strut members 212 of thedelivery cylinder 200 can also provide significant advantages duringimplant/valve deployment and recapture. For example, FIGS. 14, 15, and16 illustrate implantation of a prosthetic implant 234 configured as aheart valve in a native aortic valve 254 of a heart 258. As illustratedin FIG. 15, the delivery apparatus can be advanced through the aorta 260until the delivery cylinder 200 is positioned between the leaflets 256of the aortic valve 254. As the delivery cylinder is advanced throughthe aorta and positioned in the aortic valve, the delivery cylinder canbe in the expanded configuration or in the contracted configuration. Theprosthetic valve 234 can then be deployed from the delivery cylinder andcan at least partially expand to its functional size, as shown in FIG.16. As the prosthetic valve 234 deploys, the strut members cantransition to the contracted position. Deploying the implant/valve caninclude advancing the implant from the delivery cylinder or retractingthe delivery cylinder proximally with respect to the implant, dependingupon the particular system.

During implant/valve implantation, it may become necessary to at leastpartially recapture the implant/valve (e.g., by partially or fullywithdrawing the implant/valve back into the delivery cylinder oradvancing the delivery cylinder over the implant/valve) in order toreposition the implant/valve in the delivery position (e.g., in a nativeheart valve annulus, blood vessel, organ, etc.) or remove theimplant/valve from the body. With reference to FIG. 14, when theimplant/valve 234 is recaptured, the delivery cylinder can urge theimplant/valve back into a collapsed configuration as the implant/valveis drawn back into the cylinder in the direction of arrow 262. Duringthis process, the implant/valve 234 can exert radial forces F_(R) on thewoven liner and the strut members 212, causing the flexible member 242to expand over the implant/valve and causing the strut members to bendat the flex regions 216 such that the delivery cylinder assumes theexpanded configuration.

The implant/valve 234 can also exert axial forces F_(A) on the strutmembers 212. Because a large proportion of the radial forces F_(R) areborne by the woven liner within the second tubular portion 206, andbecause the woven liner is not axially rigid, the strut members 212 canbear the axial forces F_(A). Thus, the woven liner and the strut memberscan act synergistically to facilitate implant/valve recapture becausethe radial forces can be borne by the woven liner and the axial forcescan be borne by the strut members. As stated above, this allows thestrut members 212 to be made with a relatively thin wall thicknessbecause the strut members need only provide columnar strength, and neednot be configured to bear the full radial forces attendant tocompressing the implant back to a collapsed delivery state duringrecapture.

FIGS. 17 and 18 illustrate an embodiment in which a tubular member, suchas a second woven liner 310, is disposed around the exterior of thedelivery cylinder 200. In this example, the woven liner 310 can be sizedsuch that the strut members of the delivery cylinder are radiallyconstrained by the woven liner 310 such that the delivery cylinder is inthe collapsed configuration for insertion into the body. When thedelivery cylinder is advanced to an appropriate location in a relativelywider portion of the patient's vasculature, such as the descending aorta260, the woven liner 310 can be proximally withdrawn from over thedelivery cylinder, as shown in FIG. 18. This can allow the strut membersto bend at the flex regions (due to, for example, radial force appliedto the strut members and the inner woven liner 300 by the prostheticimplant) such that the delivery cylinder expands to the expandedconfiguration. Alternatively, instead of withdrawing the woven sheath310 proximally, the delivery cylinder can be advanced distally out ofthe woven liner and can move to the expanded configuration. In someembodiments, the tubular member 310 need not be woven, and can be madefrom any of various materials such as plastics or metals, to constrainthe delivery cylinder in the collapsed configuration.

FIG. 19 illustrates another embodiment of a delivery cylinder 400including a main body portion 402 having a first tubular portion 404 anda second tubular portion 406. The first tubular portion 404 can becouplable to a distal end portion of an outer catheter, similar to thedelivery cylinder of FIG. 3 above. The second tubular portion 406 caninclude a plurality of circumferentially arranged strut members 408extending from the first tubular portion 404 and having respective flexregions 410 located at the proximal end portions of the strut members.In the illustrated embodiment, the flex regions 410 can have a reducedmaterial thickness as compared to the main body portion of the strutmembers. This can bias the strut members to bend or flex at the locationof the flex regions 410 upon application of radial force, similar to theembodiments described above. In the illustrated embodiment, the deliverycylinder includes 12 strut members 408. However, it should be understoodthat the delivery cylinder can include any suitable number of strutmembers. The strut members can also include one or more openings 412defined at the distal end portions of the strut members to, for example,secure a flexible member on the strut members similar to the flexiblemember 242. Delivery cylinder 400 can incorporate the same or similarfeatures to those described above with respect to delivery cylinder 200,including a flexible member, one or more liners, openings, extensions,retaining mechanisms, etc.

FIG. 20 illustrates a representative method of recapturing a prostheticimplant with the delivery cylinder embodiments described herein. At afirst block 502, a prosthetic implant contained in a delivery cylinderin a radially compressed state can be deployed from the deliverycylinder. The delivery cylinder can include a plurality ofcircumferentially arranged strut members. As the prosthetic implant isdeployed from the delivery cylinder, the implant can at least partiallyexpand to a functional size, and the strut members can move radiallyinwardly from an expanded configuration to a contracted configuration.

At process block 504, the prosthetic implant can be recaptured such thatthe prosthetic implant is at least partially returned to the radiallycompressed state by the delivery cylinder, and the strut members canmove radially outwardly such that the delivery cylinder returns to theexpanded configuration.

FIG. 21 illustrates a representative method of advancing a deliveryapparatus through a sheath, such as an introducer sheath. At processblock 602, a delivery assembly including a delivery cylinder containinga prosthetic implant in a radially compressed state can be inserted intoan introducer sheath such that a plurality of circumferentially arrangedstrut members of the delivery cylinder move radially inwardly from anexpanded configuration to a contracted configuration to conform to adiameter of the introducer sheath.

At process block 604, the delivery apparatus can be advanced through theintroducer sheath and into a patient's body such that the strut membersmove radially outwardly and return to the expanded configuration.

General Considerations

It should be understood that the disclosed embodiments can be adapted todelivery and implant prosthetic devices in any of the native annulusesof the heart (e.g., the pulmonary, mitral, and tricuspid annuluses), andcan be used with any of various approaches (e.g., retrograde, antegrade,transseptal, transventricular, transatrial, etc.). The disclosedembodiments can also be used to implant prosthesis in other lumens(e.g., blood vessels, etc.) or locations in the body. Further, inaddition to prosthetic valves, the delivery assembly embodimentsdescribed herein can be adapted to deliver and implant various otherprosthetic devices such as stents, grafts, and/or other prostheticrepair devices.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatus, and systems should not be construed asbeing limiting in any way. Instead, the present disclosure is directedtoward all novel and nonobvious features and aspects of the variousdisclosed embodiments, alone and in various combinations andsub-combinations with one another. The methods, apparatus, and systemsare not limited to any specific aspect or feature or combinationthereof, nor do the disclosed embodiments require that any one or morespecific advantages be present or problems be solved.Features/components described with respect to one exemplary embodimentmay be incorporated into other embodiments disclosed herein even if notspecifically described with respect to the embodiment.

Although the operations of some of the disclosed embodiments aredescribed in a particular, sequential order for convenient presentation,it should be understood that this manner of description encompassesrearrangement, unless a particular ordering is required by specificlanguage set forth below. For example, operations described sequentiallymay in some cases be rearranged or performed concurrently. Moreover, forthe sake of simplicity, the attached figures may not show the variousways in which the disclosed methods can be used in conjunction withother methods. Additionally, the description sometimes uses terms like“provide” or “achieve” to describe the disclosed methods. These termsare high-level abstractions of the actual operations that are performed.The actual operations that correspond to these terms may vary dependingon the particular implementation and are readily discernible by one ofordinary skill in the art.

As used in this application and in the claims, the singular forms “a,”“an,” and “the” include the plural forms unless the context clearlydictates otherwise. Additionally, the term “includes” means “comprises.”Further, the terms “coupled” and “associated” generally meanelectrically, electromagnetically, and/or physically (e.g., mechanicallyor chemically) coupled or linked and does not exclude the presence ofintermediate elements between the coupled or associated items absentspecific contrary language.

In the context of the present application, the terms “lower” and “upper”are used interchangeably with the terms “inflow” and “outflow”,respectively. Thus, for example, the lower end of the valve is itsinflow end and the upper end of the valve is its outflow end.

As used herein, the term “proximal” refers to a position, direction, orportion of a device that is closer to the user and further away from theimplantation site. As used herein, the term “distal” refers to aposition, direction, or portion of a device that is further away fromthe user and closer to the implantation site. Thus, for example,proximal motion of a device is motion of the device toward the user,while distal motion of the device is motion of the device away from theuser. The terms “longitudinal” and “axial” refer to an axis extending inthe proximal and distal directions, unless otherwise expressly defined.

As used herein, the terms “integrally formed” and “unitary construction”refer to a construction that does not include any welds, fasteners, orother means for securing separately formed pieces of material to eachother.

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

In view of the many possible embodiments to which the principles of thedisclosed technology may be applied, it should be recognized that theillustrated embodiments are only preferred examples and should not betaken as limiting the scope of the disclosure. Rather, the scope of thedisclosure is at least as broad as the following claims.

What is claimed is:
 1. A delivery cylinder for a prosthetic implant, comprising: a first tubular portion; and a second tubular portion comprising a plurality of strut members coupled to the first tubular portion and defining a volume for containing a prosthetic implant in a radially compressed state, the strut members including proximal end portions and main body portions extending from the proximal end portions, the proximal end portions comprising flex regions configured such that application of force to the strut members causes deformation of the flex regions and corresponding radially inward or outward movement of the strut members relative to a longitudinal axis of the delivery cylinder between an expanded configuration and a contracted configuration, the flex regions comprising respective first and second bending portions with intermediate portions therebetween; wherein the main body portions of the strut members are substantially parallel to the longitudinal axis of the delivery cylinder when the delivery cylinder is in the expanded configuration and when the delivery cylinder is in the contracted configuration; and wherein the first bending portions of the flex regions are located proximally of the second bending portions, and are configured to bend in a direction radially away from the longitudinal axis such that angles defined between the first tubular portion and the respective intermediate portions are less than 180 degrees when the delivery cylinder is in the expanded configuration.
 2. The delivery cylinder of claim 1, wherein the second bending portions are configured to bend in a direction radially toward the longitudinal axis such that angles defined between the intermediate portions and the main portions of the strut members are greater than 180 degrees when the delivery cylinder is in the expanded configuration.
 3. The delivery cylinder of claim 1, wherein the strut members further comprise recessed portions associated with each of the first and second bending portions, the recessed portions being defined in edges of the strut members and configured to reduce a width of the strut members to induce bending at the first and second bending portions.
 4. The delivery cylinder of claim 1, further comprising a woven liner comprising a woven fabric coaxially disposed with respect to the second tubular portion.
 5. The delivery cylinder of claim 4, wherein the strut members further define one or more openings for suturing the woven liner to the strut members.
 6. The delivery cylinder of claim 4, wherein the woven liner is disposed within the second tubular portion.
 7. The delivery cylinder of claim 6, further comprising a tubular member disposed about an exterior of the second tubular portion.
 8. The delivery cylinder of claim 7, wherein the tubular member is a second woven liner comprising a woven fabric.
 9. The delivery cylinder of claim 1, wherein the first tubular portion is a distal end portion of an outer shaft of a delivery apparatus.
 10. The delivery cylinder of claim 1, further comprising a flexible member coupled to respective distal end portions of the strut members to limit radial expansion of the strut members.
 11. The delivery cylinder of claim 10, wherein the strut members further comprise one or more extension portions to engage the flexible member.
 12. A delivery apparatus including the delivery cylinder of claim
 1. 13. The delivery cylinder of claim 1, wherein the strut members of the delivery cylinder form a cylindrical arrangement in the expanded configuration and in the contracted configuration.
 14. An assembly, comprising: a shaft having a proximal end portion and a distal end portion; a delivery cylinder coupled to the distal end portion of the shaft and including a plurality of strut members defining a tubular portion, the strut members including flex regions configured such that application of force to the strut members causes deformation of the flex regions and corresponding radially inward or outward movement of the strut members relative to a longitudinal axis of the delivery cylinder between an expanded configuration and a contracted configuration, the flex regions comprising respective first and second bending portions with intermediate portions therebetween, the first bending portions being located proximally of the second bending portions and configured to bend in a direction radially away from the longitudinal axis such that angles defined between the distal end portion of the shaft and the respective intermediate portions are less than 180 degrees when the delivery cylinder is in the expanded configuration; and a prosthetic implant retained in a radially compressed state in the delivery cylinder; wherein the strut members of the delivery cylinder have a length that is greater than a length of the prosthetic implant at least when the delivery cylinder is in the expanded configuration such that the strut members retain the prosthetic implant in a radially compressed state when the delivery cylinder is in both the expanded configuration and in the contracted configuration.
 15. The assembly of claim 14, wherein the second bending portions are configured to bend in a direction radially toward the longitudinal axis such that angles defined between the intermediate portions and the main portions of the strut members are greater than 180 degrees when the delivery cylinder is in the expanded configuration.
 16. The assembly of claim 14, wherein the strut members further comprise recessed portions associated with each of the first and second bending portions, the recessed portions being defined in edges of the strut members and configured to reduce a width of the strut members to induce bending at the first and second bending portions.
 17. The assembly of claim 14, further comprising a woven liner comprising a woven fabric coaxially disposed with respect to the tubular portion.
 18. The assembly of claim 17, wherein the strut members further define one or more openings for suturing the woven liner to the strut members.
 19. The assembly of claim 17, wherein the woven liner is disposed within the tubular portion.
 20. The assembly of claim 19, further comprising a tubular member disposed about an exterior of the tubular portion of the delivery cylinder.
 21. The delivery cylinder of claim 20, wherein the tubular member is a second woven liner comprising a woven fabric.
 22. The delivery cylinder of claim 14, wherein: the strut members include proximal end portions and main body portions extending from the proximal end portions, the proximal end portions comprising the flex regions; and the main body portions of the strut members are substantially parallel to the longitudinal axis of the delivery cylinder when the delivery cylinder is in the expanded configuration and when the delivery cylinder is in the contracted configuration.
 23. A method, comprising: retracting a tubular member from over a delivery cylinder coupled to a distal end portion of a shaft or advancing the delivery cylinder from the tubular member such that a plurality of circumferentially arranged strut members of the delivery cylinder move radially outwardly from a contracted configuration to an expanded configuration, the strut members including flex regions comprising first and second bending portions with intermediate portions therebetween, the first bending portions being located proximally of the second bending portions and configured to bend in a direction radially away from a longitudinal axis of the delivery cylinder such that angles defined between the distal end portion of the shaft and the respective intermediate portions are less than 180 degrees when the delivery cylinder is in the expanded configuration; deploying a prosthetic implant contained in the delivery cylinder in a radially compressed state from the delivery cylinder such that the prosthetic implant at least partially expands to a functional size and the strut members move radially inwardly from the expanded configuration to the contracted configuration; and recapturing the prosthetic implant such that the prosthetic implant is at least partially returned to the radially compressed state by the delivery cylinder, and the strut members move radially outwardly such that the delivery cylinder returns to the expanded configuration.
 24. The method of claim 23, wherein deploying the prosthetic implant further comprises advancing the prosthetic implant from the delivery cylinder or retracting the delivery cylinder from over the prosthetic implant.
 25. The method of claim 23, wherein recapturing the prosthetic implant further comprises retracting the prosthetic implant into the delivery cylinder or advancing the delivery cylinder over the prosthetic implant.
 26. The method of claim 23, wherein the delivery cylinder comprises a first woven liner disposed within the delivery cylinder, and the tubular member is a second woven liner, the first and second woven liners comprising woven fabric.
 27. A method, comprising: inserting a delivery assembly including a delivery cylinder containing a prosthetic implant in a radially compressed state into an introducer sheath such that a plurality of circumferentially arranged strut members of the delivery cylinder move radially inwardly from an expanded configuration to a contracted configuration to conform the delivery cylinder and the prosthetic implant to a diameter of the introducer sheath, the prosthetic implant being fully contained within a volume defined by the strut members, the delivery cylinder being coupled to a distal end portion of a shaft, the strut members including flex regions comprising first and second bending portions with intermediate portions therebetween, the first bending portions being located proximally of the second bending portions and configured to bend in a direction radially away from a longitudinal axis of the delivery cylinder such that angles defined between the distal end portion of the shaft and the respective intermediate portions are less than 180 degrees when the delivery cylinder is in the expanded configuration; and advancing the delivery assembly through the introducer sheath and into a patient's body such that as the delivery cylinder exits the introducer sheath, the prosthetic implant expands the delivery cylinder and the strut members move radially outwardly and return to the expanded configuration. 